Data / Medical devices / Italy / Sorin Group Italia S.R.L
Sorin Group Italia S.R.L: FDA-registered device maker in MIRANDOLA Modena, Italy, 86 510(k) clearances
Sorin Group Italia S.R.L is registered with the FDA (registration 9680841) in MIRANDOLA Modena, Italy. It lists 16 device types. The FDA files 86 510(k) clearances under its listings, the newest dated March 11, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 9680841
- FEI number
- 3005426550
- Address
- 86, Via Statale 12 Nord, MIRANDOLA Modena, Italy, 41037
- Owner or operator
- SORIN GROUP ITALIA S.R.L (9011842)
- Roles
- Manufacturer, Specification developer
- First device listed
- September 24, 1998
- Registered through
- 2027
- Brand names listed
- A211-xx A/B/C/D/E/F/N series, A212-73 A/B/C/D/E/F, A212-xx A/B/C/D/E/F/N series, A221-xx A/B/C/D/E/F/N series, A222-xx A/B/C/D/E/F/N series, A231-xx A/B/C/D/E/F/N series, A232-xx A/B/C/N series, A232-xx D/E/F series and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 11, 2026 | K250937 | Venous Return Cannulae | DWF | Substantially Equivalent | LivaNova USA, Inc. | accessdata.fda.gov |
| January 30, 2026 | K253671 | Dual Stage Venous Cannulae | DWF | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| December 22, 2025 | K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirs | DTN | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| December 19, 2025 | K253616 | ProtekDilate Vascular Access Kit | DRE | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| July 10, 2025 | K250283 | RAP Femoral Venous Cannulae | DWF | Substantially Equivalent | LivaNova USA, Inc. | accessdata.fda.gov |
| June 27, 2025 | K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | DWF | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| May 30, 2025 | K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) | DTR | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| April 25, 2025 | K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) | KDI | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| December 20, 2024 | K242953 | KIDS Arterial Filters | DTM | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| November 18, 2024 | K242092 | MICRO Arterial Filters | DTM | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| August 16, 2024 | K241236 | XTRA Collection sets; XTRA Sequestration set X | CAC | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| April 29, 2024 | K240584 | XTRA Autotransfusion System (with XTRA Bowl sets) | CAC | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| February 22, 2024 | K240193 | R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) | DWF | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| November 16, 2023 | K231652 | D100 KIDS; D101 KIDS | DTZ | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| October 6, 2023 | K232480 | ProtekDuo Veno-Venous Cannula Sets | PZS | Substantially Equivalent | Cardiacassist, Inc. | accessdata.fda.gov |
| June 10, 2023 | K223361 | BMR 1900 PHISIO | DTN | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| July 12, 2021 | K211495 | EOS PMP | DTZ | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| April 1, 2021 | K202154 | B-Capta | DRY | Substantially Equivalent | Livanova Deutschland, GmbH | accessdata.fda.gov |
| August 13, 2020 | K201916 | Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator | DTZ | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| June 12, 2020 | K200683 | INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir | DTZ | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| August 7, 2019 | K190650 | Revolution Centrifugal Blood Pump | KFM | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| April 13, 2019 | K190690 | INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir | DTZ | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| November 16, 2018 | K180979 | PureFlex Arterial Cannulae | DWF | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| March 15, 2018 | K180448 | INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter | DTZ | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| June 16, 2017 | K162215 | Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae | DWF | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| March 8, 2017 | K161733 | INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C | DTN | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| January 6, 2017 | K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set | DRE | Substantially Equivalent | Cardiacassist, Inc. | accessdata.fda.gov |
| November 30, 2016 | K162214 | Protek Solo 24 Fr Venous Cannula Set | DWF | Substantially Equivalent | Cardiacassist, Inc. | accessdata.fda.gov |
| March 4, 2016 | K160257 | PROTEK Duo 31 Fr. Veno-Venous Cannula Set | DWF | Substantially Equivalent | Cardiacassist, Inc. | accessdata.fda.gov |
| June 11, 2015 | K150489 | EOS PMP, EOS PMP Integrated | DTZ | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| August 6, 2014 | K140999 | TANDEMHEART VENO-VENOUS CANNULA | DWF | Substantially Equivalent | Cardiacassist, Inc. | accessdata.fda.gov |
| February 12, 2014 | K133293 | 15 FR. TANDEMHEART ARTERIAL CANNULA | DWF | Substantially Equivalent | Cardiacassist, Inc. | accessdata.fda.gov |
| June 6, 2013 | K131103 | XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR | DTN | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| March 20, 2013 | K130433 | INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE | DTZ | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| February 12, 2013 | K130209 | INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED | DTZ | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| October 17, 2012 | K122844 | INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR | DTZ | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| August 24, 2012 | K122254 | INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR | DTZ | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| August 22, 2012 | K121536 | INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR | DTZ | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| July 26, 2012 | K121909 | INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR | DTZ | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| July 23, 2012 | K121229 | INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY | DTZ | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| May 30, 2012 | K120543 | TANDEMHEART FEMORAL ARTERIAL CANNULA SET | DWF | Substantially Equivalent | Cardiacassist, Inc. | accessdata.fda.gov |
| May 11, 2012 | K120185 | INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR | DTZ | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| April 5, 2012 | K113626 | INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR | DTZ | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| September 29, 2011 | K112525 | D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS | DTM | Substantially Equivalent | Parexel International | accessdata.fda.gov |
| October 5, 2010 | K101586 | XTRA AUTOTRANSFUSION SYSTEM | CAC | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| March 24, 2010 | K100507 | XRES BLOOD COLLECTION RESERVOIR | DTN | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| November 5, 2009 | K092463 | SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM | DTQ | Substantially Equivalent | Sorin Group Deutschland GmbH | accessdata.fda.gov |
| November 19, 2008 | K081313 | SH14 HEMOCONCENTRATOR | KDI | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| September 18, 2008 | K082425 | TANDEMHEART TRANSSEPTAL CANNULA- EF 72 | DWF | Substantially Equivalent | Cardiacassist, Inc. | accessdata.fda.gov |
| October 29, 2007 | K072091 | D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR | DTZ | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| September 12, 2007 | K072308 | D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED | DTM | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| January 11, 2007 | K063255 | D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED | DTM | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| June 2, 2006 | K061031 | D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W | DTZ | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| January 17, 2006 | K052570 | TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 | DWF | Substantially Equivalent | Cardiacassist, Inc. | accessdata.fda.gov |
| October 20, 2005 | K052717 | D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER | DTM | Substantially Equivalent | Dideco S.R.L. | accessdata.fda.gov |
| May 6, 2004 | K041061 | D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS | DTM | Substantially Equivalent | Dideco S.P.A. | accessdata.fda.gov |
| February 26, 2004 | K040184 | DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER | DTM | Substantially Equivalent | Cobe Cardiovascular, Inc. | accessdata.fda.gov |
| January 8, 2004 | K033987 | D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS | DTM | Substantially Equivalent | Dideco S.P.A. | accessdata.fda.gov |
| March 6, 2003 | K030462 | COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 | KFM | Substantially Equivalent | Cobe Cardiovascular, Inc. | accessdata.fda.gov |
| November 21, 2002 | K023622 | STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35 | DWF | Substantially Equivalent | Stockert Instrumente GmbH | accessdata.fda.gov |
| November 4, 2002 | K021732 | DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT | KDI | Substantially Equivalent | Dideco S.P.A. | accessdata.fda.gov |
| October 11, 2002 | K022280 | STOCKERT CORONARY PERFUSION CANNULAE | DWF | Substantially Equivalent | Stockert Instrumente GmbH | accessdata.fda.gov |
| September 5, 2002 | K020647 | DIDECO ELECTA | CAC | Substantially Equivalent | Dideco S.P.A. | accessdata.fda.gov |
| February 12, 2002 | K011835 | COBE REVOLUTION | KFM | Substantially Equivalent | Cobe Cardiovascular, Inc. | accessdata.fda.gov |
| September 17, 2001 | K012898 | MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM | DTR | Substantially Equivalent | Cobe Cardiovascular, Inc. | accessdata.fda.gov |
| June 18, 2001 | K010974 | RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET | DWF | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| March 30, 2001 | K002019 | RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET | DWF | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| January 29, 2001 | K002273 | STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE | DWF | Substantially Equivalent | Stoeckert Instrumente | accessdata.fda.gov |
| July 28, 1998 | K981601 | CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER | DWF | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| March 31, 1998 | K974897 | COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET | CAC | Substantially Equivalent | Cobe Cardiovascular, Inc. | accessdata.fda.gov |
| August 26, 1997 | K972503 | CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE | DWF | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| June 2, 1995 | K943934 | AORTIC ARCH CANNULAS | DWF | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| May 10, 1995 | K941215 | VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR | DTN | Substantially Equivalent | Sorin Biomedical, Inc. | accessdata.fda.gov |
| April 15, 1994 | K934847 | NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS | DTN | Substantially Equivalent | Sorin Biomedical, Inc. | accessdata.fda.gov |
| December 17, 1990 | K902437 | COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER | DTP | Substantially Equivalent | Cobe Laboratories, Inc. | accessdata.fda.gov |
| July 17, 1990 | K902671 | COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER | CAC | Substantially Equivalent | Cobe Laboratories, Inc. | accessdata.fda.gov |
| March 28, 1990 | K900339 | HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES | DTS | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| May 1, 1989 | K890980 | MODIFIED STOCKERT-SHILEY VENOUS CATHETER | DWF | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| August 12, 1987 | K872159 | DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES | DWF | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| July 21, 1987 | K872162 | DIDECO-SHILEY BLOOD REINFUSION BAG | CAC | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| March 23, 1987 | K870826 | ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN. | DQR | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| March 23, 1987 | K870825 | NEW MODEL STYLES FOR AORTIC ARCH CANNULA | DQR | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| May 30, 1986 | K861310 | STOCKERT-SHILEY AORTIC ROOT CANNULAE | DWF | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| May 27, 1986 | K861496 | STOCKERT-SHILEY VENOUS CATH & AORTIC ARCH CANNULA | DWF | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| April 29, 1985 | K844803 | POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE | DTP | Substantially Equivalent | Electromedics, Inc. | accessdata.fda.gov |
| December 27, 1984 | K844140 | STOCKERT-SHILEY ATRIAL LEFT VENTRICULAR VENT CATH | DWF | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
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Updated March 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.